Research Frequently Asked Questions
Ballad Health Research FAQ
Thank you for expressing interest in working with or participating in Ballad Health research programs!
We've gathered answers to some of the most common questions both patients and research sponsors have about Ballad Health research.
Common patient questions about research at Ballad Health
- What is a clinical trial?
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals.
These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians – also known as investigators – to conduct clinical trials to determine the benefits of these drugs.
Clinical trials are usually conducted in three phases (I, II and III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.
- What should I ask my doctor about before entering a clinical trial?
If you're considering participating in a clinical trial, you should discuss it with your physician and medical caregivers. You also should understand the credentials and experience of the staff and the facility involved in conducting the study.
Questions you should ask your doctor or medical caregiver:
- How long will the trial last?
- Where is the trial being conducted?
- What treatments will be used and how?
- Is there a follow-up period and how long will I have to stay in the study?
- What is the main purpose of this trial?
- How will patient safety be monitored?
- Are there any risks involved?
- What are the possible benefits?
- What are the alternative treatments besides the one being tested in the trial?
- Who is sponsoring the trial?
- Do I have to pay for any part of the trial?
- What happens if I am harmed by the trial?
- Can I opt to remain on this treatment, even after termination of the trial?
These questions can help you gather important health and safety information about a trial you're considering enrolling in. Before becoming part of a trial, you'll want to ensure that your questions or concerns are addressed.
- What are the benefits and risks of joining a clinical study?
Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.
Please note that volunteers may withdraw from a study at any time for any reasons.
- Play an active role in your healthcare beyond standard treatment options.
- Gain access to research treatments before they are widely available.
- Obtain medical care at healthcare facilities during the trial.
- Help others by contributing to important medical research.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The treatment may not be entirely effective.
- Trial protocols may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
Common sponsor or researcher questions
- What are the recognized Good Clinical Practice (GCP) training requirements for Ballad Health?
CITI training is required for all personnel and incoming researchers within Ballad Health. The training includes GCP, conflict of interest (COI), and biomedical or human subject protection (HSP) courses.
- Does Ballad Health have an Institutional Review Board (IRB)?
Yes, the Ballad Health Institutional Review Board oversees studies completed using Ballad Health patients, physicians and facilities.
- When do I use the IRB? When does it meet?
The Ballad Health IRB meets on the second Tuesday of each month. Submissions for upcoming full board meetings are required to be submitted no later than 14 days in advance of the meeting.
Each submission has an expiration date of 1 year. After expiration, you have the opportunity to renew your study for another year at the annual review.
- How do I gain access to use the Ballad Health IRB?
You will need to use IRBNet to complete the application process for your planned research study.
CITI training must be completed prior to being granted access to IRBNet. You may register for the IRBNet ahead of completion of your CITI training, but you will not be able to submit any forms to the IRB in support of your application until you upload your training certificates into IRBNet.
- How much time is taken within Ballad Health between the site selection letter and SIV date?
Generally, our turnaround time after receiving the site selection letter is around 6-12 weeks.
- How does Ballad Health work with external physicians regarding research study approval?
- Physician or researcher is a Ballad Health employee or consultant – The Ballad Health IRB is used to gain approval and move forward.
- Physician or researcher is an ETSU physician / researcher – Approval must be secured from the ETSU IRB before sending for approval through the Ballad Health IRB.
- Physician or researcher is from an organization without an IRB and Ballad Health patients, facilities or data are going to be used in the study – The Ballad Health IRB must be used as the primary IRB.
- What is the operational plan for the research department team within Ballad Health?
The Ballad Health research department is set up as a principal investigator (PI)-centric organization.
- Does the Ballad Health research team have backup staffing potential?
All Ballad Health studies have both primary and backup coordinator team members assigned at the start of the study. This also applies to PI team members.
- How can I securely contact the Ballad Health research department to start review of potential studies?
You can reach out to our research team members by emailing BHresearchstartup@balladhealth.org.
- Does Ballad Health have the potential to conduct studies at multi-site locations?
Absolutely! Ballad Health is a 21-hospital system throughout Northeast Tennessee and Southwest Virginia.
Our team can accommodate multi-site facility studies using either a central PI concept or using each site as a stand-alone entity with a primary PI.
- Does Ballad Health have an EMR system for direct access by sponsor personnel?
Ballad Health utilizes Epic to maintain electronic patient records.
Our team can provide direct access to Epic for monitors while on site or via remote monitoring events. Requests for monitoring must be submitted 15 days prior to visit.
Anyone with access must submit the request in writing and sign for permission/authorization. Records of restricted subject data will be provided for a finite time frame.
- Does Ballad Health have access to electronic regulatory files?
Ballad Health does not currently have an electronic regulatory file system. However, we can interact with designated monitors with records for remote, offsite visits.
We use SharePoint for file directories and follow current ICH standards for file systems.
Have any other questions that aren’t answered here?
If you have any questions we didn't answer, please reach out to us at BHresearchstartup@balladhealth.org.